BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4111907 · Received September 23, 2014

    Report

    Report Number
    1416980-2014-32909
    Event Type
    Injury
    Date Received
    September 23, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED PERITONITIS ON AN UNREPORTED DATE IN (B)(6) 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IN THE SAME MONTH AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. THE PATIENT WAS TREATED WITH CEFAZOLINE (INTRAPERITONEALLY, DOSE AND FREQUENCY NOT REPORTED), TOBRAMYCIN (INTRAPERITONEALLY, DOSE AND FREQUENCY NOT REPORTED) AND INJECTION CEZIME (INTRAVENOUS, DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. TREATMENT WITH CEFAZOLINE AND TOBRAMYCIN WERE LATER DISCONTINUED AND CEZIME THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT THE PATIENT WAS STILL HOSPITALIZED AND HAD NOT RECOVERED FROM THE EVENT. CAPD THERAPY WAS DISCONTINUED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590788 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R MINICAP, TITANIUM ADAPTER| DIANEAL AND EXTRANEAL